GABA PlasmakineticsNCT04086108
Relative Oral Bioavailability of GABA From Tomatoes
A study testing Tomato, GABA supplement and Glutamate supplement in people with GABA Plasmakinetics, run by Wageningen University at 1 site in Netherlands.
Trial summary
In this four-way crossover study, a plasmakinetic profile of GABA from tomatoes as compared to a gamma-aminobutyric acid (GABA) supplement in healthy young men will be established. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- GABA Plasmakinetics
- What is being tested?
- Tomato, GABA supplement and Glutamate supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Nov 2019to 5 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 25 kg/m2
- Age is between 18 and 28 years
- Good general health
- Male
- Veins suitable for blood sampling
- Able to speak Dutch
Who cannot join
- Is currently suffering from a disease including mental disorders
- Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
- Haemoglobin (Hb) level < 8.5 mmol/L
- Has used medication in the two months before and/or during the intervention. Occasional use of NSAIDs or paracetamol (<once a week on average) are is allowed.
- Reported weight loss or weight gain of > 2 kg in the month prior to the intervention
- Use of dietary supplements, 3 weeks before-, or during the intervention.
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- Allergic to products that are provided as part of the standardised diet
- Unwilling to consume the products that are part of the standardised diet
- Allergic to tomatoes
- (History of) drug abuse, in this case meaning >1 x per month use of recreational drugs
- Smoking
- Alcohol consumption of >10 standardised glasses per week.
- Not able to refrain from alcohol consumption 2 days before each test day
- Recent or planned blood donation (<3 month prior to first study day or during intervention)
- Personnel of Wageningen University, department of Human Nutrition and Health,
- Currently participating in other research or was participating in another study within 1 month of the intervention or within 3 months if invasive procedures were used.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen
About this study
Official title: Plasmakinetics of GABA From Tomatoes as Compared to GABA From a Supplement, After a Single Oral Administration in Healthy Young Men
In this four-way crossover study, a plasmakinetic profile of GABA from tomatoes as compared to a gamma-aminobutyric acid (GABA) supplement in healthy young men will be established. In addition, a plasmakinetic profiles of glutamate from a supplement and from tomatoes as well as the effects of glutamate from tomatoes and a supplement on the GABA plasma levels will be determined. This study will therefore provide information about the effect of a food matrix on GABA plasmakinetics.
- Conditions
- GABA Plasmakinetics
- Being tested
- Tomato, GABA supplement, Glutamate supplement
- Keywords
- GABA, Glutamate, Tomato, Plasmakinetics, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomatoDietary supplement
A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.
GABA supplementDietary supplement
Also called Gamma-aminobutyric acid
1 gram of GABA dissolved in water.
Glutamate supplementDietary supplement
A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.
| Study group | Role | What they receive |
|---|---|---|
| Tomato | Experimental | Single oral administration Receives: Dietary Supplement: Tomato |
| GABA supplement | Experimental | Single oral administration Receives: Dietary Supplement: GABA supplement |
| Glutamate supplement | Experimental | Single oral administration Receives: Dietary Supplement: Glutamate supplement |
| Placebo | No intervention | Single oral administration, same volume of water that is distributed in the other arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA
After intake of a GABA supplement and tomatoes.
Measured: 6 months
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA
After intake of a GABA supplement and tomatoes.
Measured: 6 months
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA
After intake of a GABA supplement and tomatoes.
Measured: 6 months
Half-life (T1/2) of plasma-time curves of GABA
After intake of a GABA supplement and tomatoes.
Measured: 6 months
Secondary outcomes (8)
Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate
After intake of a glutamate supplement and tomatoes
Measured: 6 months
Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate
After intake of a glutamate supplement and tomatoes
Measured: 6 months
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate
After intake of a glutamate supplement and tomatoes
Measured: 6 months
Half-life (T1/2) of plasma-time curves of glutamate
After intake of a glutamate supplement and tomatoes
Measured: 6 months
Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.
This will be compared to the plasma time-curves of GABA after tomato intake.
Measured: 6 months
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement.
This will be compared to the plasma time-curves of GABA after tomato intake.
Measured: 6 months
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.
This will be compared to the plasma time-curves of GABA after tomato intake.
Measured: 6 months
Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.
This will be compared to the plasma time-curves of GABA after tomato intake.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start4 Nov 2019
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GABA PlasmakineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For the study, research subjects will visit the university on four test days separated by a wash out period of one week.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nunhems, Agrico Research, Avebe
- Responsible party
- Sponsor
- Investigators
- Renger Witkamp, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086108
- Sponsor's protocol ID
- 19/13
- Status last verified
- Jan 2020
- First submitted
- 18 Jun 2019
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Bie TH, Balvers MGJ, de Vos RCH, Witkamp RF, Jongsma MA. The influence of a tomato food matrix on the bioavailability and plasma kinetics of oral gamma-aminobutyric acid (GABA) and its precursor glutamate in healthy men. Food Funct. 2022 Aug 15;13(16):8399-8410. doi: 10.1039/d2fo01358d.
PubMed 35852458
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasmakinetics of GABA From Tomatoes as Compared to GABA From a Supplement, After a Single Oral Administration in Healthy Young Men
- ClinicalTrials.gov ID
- NCT04086108
- Acronym / sponsor ID
- 19/13
- Conditions
- GABA Plasmakinetics
- Keywords
- GABA, Glutamate, Tomato, Plasmakinetics, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Nunhems, Agrico Research, Avebe
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this four-way crossover study, a plasmakinetic profile of GABA from tomatoes as compared to a gamma-aminobutyric acid (GABA) supplement in healthy young men will be established. In addition, a plasmakinetic profiles of glutamate from a supplement and from tomatoes as well as the effects of glutamate from tomatoes and a supplement on the GABA plasma levels will be determined. This study will therefore provide information about the effect of a food matrix on GABA plasmakinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- For the study, research subjects will visit the university on four test days separated by a wash out period of one week.
| Arm | Type | Receives |
|---|---|---|
| Tomato | Experimental | Dietary Supplement: TomatoSingle oral administration |
| GABA supplement | Experimental | Dietary Supplement: GABA supplementSingle oral administration |
| Glutamate supplement | Experimental | Dietary Supplement: Glutamate supplementSingle oral administration |
| Placebo | No intervention | –Single oral administration, same volume of water that is distributed in the other arms |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI between 18.5 and 25 kg/m2
- Age is between 18 and 28 years
- Good general health
- Male
- Veins suitable for blood sampling
Key exclusion criteria (16 listed)
- Is currently suffering from a disease including mental disorders
- Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
- Haemoglobin (Hb) level < 8.5 mmol/L
- Has used medication in the two months before and/or during the intervention. Occasional use of NSAIDs or paracetamol (<once a week on average) are is allowed.
- Reported weight loss or weight gain of > 2 kg in the month prior to the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TomatoA maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA. | Dietary supplement | Tomato |
| GABA supplementAlso: Gamma-aminobutyric acid1 gram of GABA dissolved in water. | Dietary supplement | GABA supplement |
| Glutamate supplementA maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water. | Dietary supplement | Glutamate supplement |
Primary outcome
Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA
Time frame: 6 months
After intake of a GABA supplement and tomatoes.
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA
Time frame: 6 months
After intake of a GABA supplement and tomatoes.
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA
Time frame: 6 months
After intake of a GABA supplement and tomatoes.
Half-life (T1/2) of plasma-time curves of GABA
Time frame: 6 months
After intake of a GABA supplement and tomatoes.
8 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of plasma-time curves of glutamate
Time frame: 6 months
Peak Plasma Concentration (Cmax) of plasma-time curves of glutamate
Time frame: 6 months
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of glutamate
Time frame: 6 months
Half-life (T1/2) of plasma-time curves of glutamate
Time frame: 6 months
Area under the plasma concentration versus time curve (AUC) AUC of plasma-time curves of GABA in response to a glutamate supplement.
Time frame: 6 months
Peak Plasma Concentration (Cmax) of plasma-time curves of GABA in response to a glutamate supplement.
Time frame: 6 months
Time to Peak Plasma Concentration (Tmax) of plasma-time curves of GABA in response to a glutamate supplement.
Time frame: 6 months
Half-life (T1/2) of plasma-time curves of GABA in response to a glutamate supplement.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Derived from this study: PubMed 35852458de Bie TH, Balvers MGJ, de Vos RCH, Witkamp RF, Jongsma MA. The influence of a tomato food matrix on the bioavailability and plasma kinetics of oral gamma-aminobutyric acid (GABA) and its precursor glutamate in healthy men. Food Funct. 2022 Aug 15;13(16):8399-8410. doi: 10.1039/d2fo01358d.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renger Witkamp, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomato, GABA supplement and Glutamate supplement in people with GABA Plasmakinetics, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC ) of plasma-time curves of GABA (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.